Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency

Rafael Dal-Re, David Moher, Christian Gluud, Shaun Treweek, Jacques Demotes-Mainard, Xavier Carne

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    12 Citations (Scopus)

    Abstract

    * Many clinical trials are terminated before reaching the sample size needed to test the trials' hypotheses owing to poor recruitment.
    * Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public.
    * Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available.
    * We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided.
    * This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks.
    * Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.
    Original languageEnglish
    Article numbere1001149
    Pages (from-to)-
    Number of pages4
    JournalPLoS Medicine
    Volume8
    Issue number12
    DOIs
    Publication statusPublished - Dec 2011

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